The following data is part of a premarket notification filed by American Dade with the FDA for Ion Selective Electrode Subsystem Paramax Analyzer.
Device ID | K853531 |
510k Number | K853531 |
Device Name: | ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER |
Classification | Electrode, Ion Specific, Potassium |
Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Contact | James E Keller |
Correspondent | James E Keller AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Product Code | CEM |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-23 |
Decision Date | 1985-09-04 |